Yescarta (axicabtagene ciloleucel)

Axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel) are standard-of-care second-line therapies for relapsed or refractory large B-cell lymphomas, yet clinical and immunological predictors of durable benefit remain poorly defined. Greater CART expansion, enrichment for naïve CD8+ CAR+ T-cells, and lower PD1 expression at day 7 post-infusion are associated with response. Thus, these findings highlight the efficacy of second-line CART and identify disease and immune-related predictors of long-term response.

P2, N=20, Recruiting, Zhejiang Cancer Hospital | Not yet recruiting --> Recruiting

P3, N=550, Recruiting, Kite, A Gilead Company | Not yet recruiting --> Recruiting

Axi-cel demonstrated substantial efficacy in Japanese patients with r/r LBCL. The 2L setting was associated with higher toxicity and numerically higher PFS.

We conducted a multicenter retrospective study using the French DESCAR-T registry, including patients with LBCL who relapsed after 2L CAR T-cell therapy with axicabtagene ciloleucel or lisocabtagene maraleucel. This study represents the first real-world analysis of outcomes after relapse following 2L CAR T-cell therapy. Despite the more frequent incorporation of BsAbs into the therapeutic landscape, overall prognosis and treatment efficacy remain dismal, highlighting the urgent need for innovative therapeutic strategies and dedicated prospective trials in this emerging double-refractory population.

P2, N=20, Not yet recruiting, Zhejiang Cancer Hospital

We report a case of severe, irreversible transverse myelitis following CD19-directed CAR-T cell therapy (axicabtagene ciloleucel) for refractory post-transplant lymphoproliferative disorder (PTLD) in a young female lung-transplant recipient...We further address diagnostic challenges, and review current management strategies such as corticosteroids, IL-1 blockade, and IL-6 neutralization. This report underscores the need for heightened vigilance, early imaging, and systematic reporting to improve prevention and treatment of this rare but severe CAR-T-related neurotoxicity.

P3, N=300, Active, not recruiting, Kite, A Gilead Company | Recruiting --> Active, not recruiting

These findings highlight the importance of early leukapheresis, ideally before intensive treatments, to optimize T-cell yield, product quality, and therapeutic efficacy.

Our study indicates that CAR T-cell levels after axi-cel correlate to durable response, progression-free survival, and that expansion of CD8+ CAR T-cells might be of specific importance for efficacy. Potentially, CAR T-cell levels may be used to enable early detection of patients with high risk of CAR T-cell treatment failure.

P4, N=75, Not yet recruiting, Universitair Ziekenhuis Gent

P3, N=550, Not yet recruiting, Kite, A Gilead Company